Novo Nordisk receives FDA approval for higher-dose Ozempic
Novo Nordisk has gained the Food and Drug Administration’s green light for a 2-mg dose of Ozempic (semaglutide) injection.
The medication is a once-weekly glucagon-like peptide-1 analog indicated, along with diet and exercise, to improve blood sugar in adults with Type 2 diabetes and to reduce the risk of major cardiovascular events, such as heart attack, stroke or death in adults with Type 2 diabetes and known heart disease.
“Type 2 diabetes is a complex disease that can progress over time even if a person is managing it with medication, diet and exercise,” said Juan Pablo Frias, medical director of Velocity Clinical Research in Los Angeles and principal investigator of the SUSTAIN FORTE clinical trial. “With its proven safety and efficacy, Ozempic helps deliver on blood glucose control and offers major cardiovascular event risk reduction in adults with Type 2 diabetes and known heart disease, plus it can help many patients lose some weight. With a 2-mg dose, we have an additional option so patients can stay on the same medication therapy even if their blood sugar needs shift.”
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Ozempic will be available in three therapeutic doses--0.5 mg, 1 mg and 2 mg--to help people with Type 2 diabetes reach their blood sugar (A1C) goal, including those with a higher A1C and have been unable to meet their target.
“Ozempic is at the helm of helping Novo Nordisk drive change in diabetes care, with more than 1 million people with Type 2 diabetes in the United States treated with Ozempic,” Doug Langa, executive vice president, North America operations and president of Novo Nordisk, said. “With Ozempic now available in a variety of dosing strengths, we are optimistic we can help even more people living with Type 2 diabetes who require more blood sugar control experience the benefits of Ozempic.”
Novo Nordisk said it expects to launch Ozempic 2 mg in the United States shortly.
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